EP3648778B1 - High potency stable formulations of vaginal lactobacillus - Google Patents

High potency stable formulations of vaginal lactobacillus

Info

Publication number
EP3648778B1
EP3648778B1 EP18827562.2A EP18827562A EP3648778B1 EP 3648778 B1 EP3648778 B1 EP 3648778B1 EP 18827562 A EP18827562 A EP 18827562A EP 3648778 B1 EP3648778 B1 EP 3648778B1
Authority
EP
European Patent Office
Prior art keywords
lactobacillus
vaginal
preservation medium
dry powder
powder
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP18827562.2A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3648778C0 (en
EP3648778A4 (en
EP3648778A1 (en
Inventor
Thomas P. Parks
Angela MARCOBAL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Osel Inc
Original Assignee
Osel Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Osel Inc filed Critical Osel Inc
Publication of EP3648778A1 publication Critical patent/EP3648778A1/en
Publication of EP3648778A4 publication Critical patent/EP3648778A4/en
Application granted granted Critical
Publication of EP3648778C0 publication Critical patent/EP3648778C0/en
Publication of EP3648778B1 publication Critical patent/EP3648778B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00—Microorganisms; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/04—Preserving or maintaining viable microorganisms
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00—Microorganisms; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/20—Bacteria; Culture media therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K2035/11—Medicinal preparations comprising living procariotic cells
    • A61K2035/115—Probiotics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Microbiology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Virology (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • General Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Endocrinology (AREA)
  • Dispersion Chemistry (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
EP18827562.2A 2017-07-07 2018-07-05 High potency stable formulations of vaginal lactobacillus Active EP3648778B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762529756P 2017-07-07 2017-07-07
PCT/US2018/040884 WO2019010282A1 (en) 2017-07-07 2018-07-05 STABILIZED FORMULATIONS WITH HIGH POWER OF LACTOBACILLUS VAGINAL

Publications (4)

Publication Number Publication Date
EP3648778A1 EP3648778A1 (en) 2020-05-13
EP3648778A4 EP3648778A4 (en) 2021-05-05
EP3648778C0 EP3648778C0 (en) 2026-05-13
EP3648778B1 true EP3648778B1 (en) 2026-05-13

Family

ID=64950361

Family Applications (1)

Application Number Title Priority Date Filing Date
EP18827562.2A Active EP3648778B1 (en) 2017-07-07 2018-07-05 High potency stable formulations of vaginal lactobacillus

Country Status (7)

Country Link
US (3) US20200171107A1 (enExample)
EP (1) EP3648778B1 (enExample)
JP (1) JP7347760B2 (enExample)
CN (1) CN110869036B (enExample)
AU (1) AU2018298117B2 (enExample)
ES (1) ES3074462T3 (enExample)
WO (1) WO2019010282A1 (enExample)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2018298116A1 (en) * 2017-07-07 2020-02-27 Aarhus Universitet Use of vaginal lactobacilli for improving the success rate of in vitro fertilization
WO2019010282A1 (en) * 2017-07-07 2019-01-10 Osel, Inc. STABILIZED FORMULATIONS WITH HIGH POWER OF LACTOBACILLUS VAGINAL
TWI737210B (zh) * 2020-03-06 2021-08-21 財團法人食品工業發展研究所 菌酛保護劑配方及其用途
CN113755357A (zh) * 2020-06-04 2021-12-07 内蒙古伊利实业集团股份有限公司 一种乳杆菌制剂及其用途
US20250345375A1 (en) 2021-02-19 2025-11-13 Imperial College Innovations Limited Lactobacillus crispatus composition for use in pregnant subjects
EP4301386A1 (en) * 2021-03-03 2024-01-10 Freya Biosciences ApS Vaginal microbiota-associated methods, compositions, and devices
US12185767B2 (en) * 2021-11-05 2025-01-07 Trillium Medical Products, LLC Infused undergarment
WO2025016986A1 (en) * 2023-07-14 2025-01-23 Dsm Ip Assets B.V. Lactic acid bacteria composition

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2463768A (en) * 1945-09-05 1949-03-08 Phillips Petroleum Co Alkylation process
US3897307A (en) * 1974-10-23 1975-07-29 Hansens Lab Inc Stabilized dry cultures of lactic acid-producing bacteria
US6093941A (en) 1993-09-09 2000-07-25 The United States Of America As Represented By The Secretary Of The Navy Photonic silicon on a transparent substrate
DK0924993T3 (da) * 1996-09-10 2002-01-28 Nestle Sa Afvandede fødevarer indeholdende mælkesyrebakterier
US6093394A (en) * 1997-04-11 2000-07-25 Gynelogix, Inc. Vaginal lactobacillus medicant
SE521022C2 (sv) * 2001-09-20 2003-09-23 Ellen Ab Mjölksyraproducerande bakterier för användning som probiotiska organismer i vaginan hos människa
US20110066137A1 (en) * 2007-12-18 2011-03-17 Osel, Inc. Applicator for applying powder formulations and uses thereof
WO2009123982A2 (en) * 2008-03-31 2009-10-08 Osel, Inc. Transiently buffered lactobacillus preparations and use thereof
US8329447B2 (en) 2008-12-12 2012-12-11 Osel, Inc. Strain of Lactobacillus crispatus
ES2425385T3 (es) * 2009-04-30 2013-10-15 Actogenix N.V. Crioprotectores para la liofilización de las bacterias de ácido láctico
CL2011001984A1 (es) * 2010-08-13 2012-06-29 Advanced Bionutrition Corp Composicion seca estabilizadora para material biologico que comprende carbohidrato, proteinas hidrolizadas de animal o de planta y un componente de acido carboxilico; metodo de preparacion; y formulacion de entrega oral que comprende la composicion seca estabilizadora.
FR2992973B1 (fr) * 2012-07-09 2015-12-18 S P M D Nouvelle souche de lactobacillus crispatus
CN102757922B (zh) 2012-07-30 2013-11-20 陕西省科学院酶工程研究所 嗜酸乳杆菌复合冻干保护剂及其制备和使用方法
MX2015006491A (es) * 2012-11-23 2015-12-03 Seres Health Inc Composiciones bacterianas sinergicas y metodos de produccion y uso de las mismas.
WO2014106541A1 (en) * 2013-01-04 2014-07-10 Ellen Ab Dermal composition for use in the external genital area in females
CN104178437B (zh) * 2013-11-08 2016-08-24 苏州欧赛微科生物医药科技有限公司 一种卷曲乳杆菌及其在妇科疾病中的应用
US9937214B2 (en) * 2013-11-08 2018-04-10 Suzhou Osel Bio-Pharm Co., Ltd. Lactobacillus crispatus and application thereof
WO2017073752A1 (ja) * 2015-10-30 2017-05-04 株式会社ヤクルト本社 微生物乾燥菌体の製造方法
WO2019010282A1 (en) * 2017-07-07 2019-01-10 Osel, Inc. STABILIZED FORMULATIONS WITH HIGH POWER OF LACTOBACILLUS VAGINAL

Also Published As

Publication number Publication date
JP7347760B2 (ja) 2023-09-20
AU2018298117B2 (en) 2024-08-08
WO2019010282A1 (en) 2019-01-10
CN110869036A (zh) 2020-03-06
EP3648778C0 (en) 2026-05-13
US11083761B2 (en) 2021-08-10
AU2018298117A1 (en) 2020-02-27
US20200171107A1 (en) 2020-06-04
CN110869036B (zh) 2025-05-02
US20200230183A1 (en) 2020-07-23
CA3068958A1 (en) 2019-01-10
EP3648778A4 (en) 2021-05-05
EP3648778A1 (en) 2020-05-13
US20210330721A1 (en) 2021-10-28
JP2020526583A (ja) 2020-08-31
US12303538B2 (en) 2025-05-20
ES3074462T3 (en) 2026-07-21

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